Catheter Operator III
Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
• Performs assembly of disposable medical devices per documented production procedures. Ability to meticulously handle and maneuver small components with various manufacturing processes.
• Maintain accurate record keeping in Lot/Device History Records to document production activity and component traceability.
• Effectively communicate ideas and issues with operations team and engineering to promote solutions-oriented problem solving.
• Leads lower or equal level operators by openly training and instructing them as needed.
• Perform in-process inspection(s) and lot release testing to confirm product specifications and performance are met.
• Assist engineers with process improvement, process development activities such as prototype or test sample assembly, data collection and entry, and constructive process feedback.
• Understand kitting and line clearance processes to ensure inventory management requirements are continuously met.
• Works on multiple processes in a dynamic development/ production environment.
• Participate in continuous improvement/quality initiatives to enhance production processes to achieve quality and profitability metrics.
• Follow safety guidelines and utilize appropriate safety devices when performing all operations.
Minimum of 5 years of experience in low or high-volume production. A working knowledge in the following areas:
• Catheter experience or fiber optics assembly experience preferred.
• Prior microscope and medical assembly experience
• Ability to perform delicate, repetitive tasks. Position may require using microscope up to 8 hours per day.
• Experience working in a cleanroom environment preferred.
• Ability to physically handle small, delicate parts.
• Ability to read and understand work instructions, process guidelines, visual workmanship standards, and technical drawings.
• Understand and perform in-process inspection to assure workmanship and quality of in-process medical devices.
• Ideal candidate would have experience in start-up environments and have start-up mentality; fast learner, willingness to learn, ability to work in constantly changing work environment.
High school diploma or GED required.
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